Proact, Ltd. FDA Record
- Latest inspection NAI · Sep 12, 2019
- No warning letters matched by name
Proact, Ltd. has 0 FDA recalls, 3 inspections, 7 510(k) clearances and 0 compliance actions on record. No FDA warning letter addressed to "Proact, Ltd." is on file.
- Latest inspection
- Sep 12, 2019 · NAI
- Latest 510(k)
- Apr 12, 2006
Summary
| Records | Count | Last refreshed | Source as of | Status |
|---|---|---|---|---|
| Recalls | 0 | Nov 11, 2026 (checked Nov 15, 2026, unchanged) | File dated Nov 10, 2026 | Current |
| 510(k) clearances | 7 | Nov 15, 2026 | File dated Nov 9, 2026 | Current |
| Inspections | 3 | Nov 15, 2026 | Newest record Nov 5, 2026 | Current |
| Compliance actions | 0 | Nov 2, 2026 | Newest record Oct 29, 2026 | Current |
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Recent FDA inspections
| Date | Site | Product | Classification | FEI |
|---|---|---|---|---|
| Sep 12, 2019 | Centre Hall, PA | Devices | No Action Indicated (NAI) | 2183839 |
| Jan 15, 2013 | Centre Hall, PA | Devices | No Action Indicated (NAI) | 2183839 |
| Mar 6, 2012 | Eagan, MN | Food/Cosmetics | No Action Indicated (NAI) | 3004811699 |
- NAI
- No objectionable conditions or practices were found during the inspection.
- VAI
- Objectionable conditions or practices were found, but the agency is not prepared to take or recommend any administrative or regulatory action.
- OAI
- Regulatory and/or administrative actions are recommended.
FDA-inspected facilities
| Facility | Location | Inspections | Latest |
|---|---|---|---|
| FEI 2183839 | Centre Hall, PA | 2 | Sep 12, 2019 |
| FEI 3004811699 | Eagan, MN | 1 | Mar 6, 2012 |
Recent 510(k) clearances
| K-Number | Device | Date |
|---|---|---|
| K052243 | PROACT WITH GEL OR PROACT 1 | Apr 12, 2006 |
| K003909 | PROACT 1 | Jun 13, 2001 |
| K941256 | QUICK CORE II | Jul 13, 1994 |
| K926559 | PROACT BIOPSY NEEDLE ENCHANCEMENTS | Mar 22, 1993 |
| K913306 | BONE-TEMNO/STERNUM-TEMNO | Nov 1, 1991 |
| K902320 | BAUER FLEXI-TEMNO BIOPSY NEEDLE | Oct 1, 1990 |
| K902319 | BAUER TEMNO BIOPSY NEEDLE | Sep 6, 1990 |
Proact, Ltd. and the FDA: common questions
Has Proact, Ltd. received an FDA warning letter?
No FDA warning letter addressed to the name "Proact, Ltd." is on file. This answer covers that name only: letters addressed to a related company name or to one of its sites are listed on that name's or site's own page.
Has Proact, Ltd. received an FDA Form 483?
FDA has not published a Form 483 for "Proact, Ltd." in its reading room. FDA publishes some Form 483s, not all of them.
When did the FDA last inspect Proact, Ltd.?
The most recent FDA inspection on file ended Sep 12, 2019 at Centre Hall, PA and was classified NAI. FDA has 3 inspections of Proact, Ltd. on file.
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